| BackgroundCataract is the leading cause of blindness in the world,which account for 46%of global 40 to 45 million blind people.There are over 5 million cataract patients in China,among which nearly 2 million patients are in urgent need of surgical treatment.Additionally,there are about 0.4?1.2 million new cataract patients increased each year.In nowadays,with the beginning of "vision 2020" and the popularization of modern cataract surgery,cataract surgical rate(CSR)per million people in China was more than 1500 in 2015,but still far away from eliminating the cataract blindness.With the arrival of the aging society and the improvement of life expectancy,the number of age-related cataract would continue to increase greatly.So,we should also pay much attention to the surgery quality and recovery,so as to improve the visual quality and quality of life of the patients.The only effective treatment for cataract is the operation to remove the turbid lens and implant the intraocular lens.At present,the phacoemulsification combined with posterior chamber single focus foldable intraocular lens(SIOL)is the most commonly used surgical methods for cataract.The surgical incision has been reduced to 3 mm with many advantages such like very small tissue damage,no need to suture of incision,shortened operation time,fast recovery of visual acuity,little effect on corneal astigmatism and using surface anesthesia etc.Therefore,many people believe that the operation should be effective,painless and riskless with satisfactory visual acuity.However,we found that there were still some patients with poor vision after surgery,and some patients with pain,foreign body sensation,dry eyes or other uncomfortable symptoms.Through literatures review,we found that in China much more attention had been focused on the visual quality of new type of artificial lens,however,there was rare large-sample study concerned about the surgical results,surgical complications and postoperative uncomfortable symptoms of the surgery adoptted conventional 3mm,incision.Furthermore,visual acuity is the most commonly used method for evaluating surgical indication and postoperative recuperation.However,visual acuity can only reflect the visual function of the macular under high contrast sensitivity.It can not reflect the visual function needed in patients' daily activities.Correspondingly,patient-reported outcome(PRO),as a good and important supplement for the clinical efficacy evaluation,has been more and more used as the auxiliary method for evaluating recovery in the world.Especially the PRO questionnaires verified by Rasch analysis have got more and more attention in recent years.However,among such a large number questionnaires existed,it is really a challenge to choose a most suitable,sensitive and efficient questionnaire for northern Chinese.In this field,the Chinese version of Catquest-8SF has been proved to be of good applicability to cataract patients in southern China,but the applicability for northern Chinese patients has yet to be clarified.In conclusion,the number of patients with age-related cataract is huge in China,and so is the number of phacoemulsification with posterior chamber SIOL.It will be of great practical significance if we can improve the visual quality and quality of life of age-related cataract patients by focusing on the clinical outcome and patient-reported outcome of the operation.Research Purpose1.To assess the clinical outcome of phacoemulsification with posterior chamber SIOL.In this part,we would mainly observe the visual acuity recovery and surgical complications,and then evaluate the factors that affect the recovery of vision,and discuss the harm and the prevention of surgical complications.2.To study the patient-reported outcome of phacoemulsification with posterior chamber SIOL using The Chinese version of Catquest-8SF questionnaire.We would mainly evaluate the applicability of Catquest-8SF scale in northern China and evaluate its sensitivity to cataract surgery.3.To evaluate the satisfaction of phacoemulsification with posterior chamber SIOL and its related factors.Through the above aspects of the study,we wanted to evaluate the quality and effect of phacoemulsification comprehensively,so as to provide better clinical guidance for postoperative recovery and to improve the visual quality and life quality of the age-related cataract patients.Materials and Method1.Case selectionSequential clinical case study has been applied in present study.Age-related cataract patients who undergone phacoemulsification with posterior chamber SIOL were included in the study in Central Hospital of Tai'an.The exclusion criteria were:1.implantation of multifocal intraocular lenses;2.with history of severe ocular trauma;3.with psychiatric disorders or cognitive diseases.2.Preoperative examination and treatmentRoutine physical and ocular examinations were performed to rule out contraindications.Preoperative ocular examinations included the tests of visual acuity,slit lamp microscope,noncontact intraocular pressure,direct ophthalmoscope,corneal curvature and axial length.Furthermore,the SRK/T formula was used to calculate the diopter of intraocular lens.The lacrimal passage irrigation was performed before the operation to rule out dacryocystitis.The B-mode ultrasound was applied to examine whether there was retinal detachment or severe vitreous opacity.Optical coherence tomography(OCT)was used for patients with suspected macular disease.The examination of visual field,optic nerve OCT and 24 hour intraocular pressure were performed for the patients with high intraocular pressure or increasing cup disc ratio.Gatifloxacin or tobramycin and pranoprofen eye drops were given 1-2 days before the operation.Presenting visual acuity(PVA)was used to record the vision which meant that the patients who normally didn't wear glasses would be recorded the sight of the naked eyes,and the patients who normally weared glasses would be recorded the corrected visual acuity.3.Operation methodPatients were given compound tropicamide eye drops(1ml:5mg and 5mg tropicamide phenylephrine hydrochloride)half an hour before operation for mydriasis.0.04%oxybuprocaine surface anesthesia was given 3 times before the surgery.Routine eye disinfection was done before opening eyelid by blepharostat.Puncture at 2 point of the corneal limbus with 15° knife and sodium hyaluronate was injected into the anterior chamber.3mm clear corneal incision was made at 10 point of the corneal limbus,and continuous circular capsulorhexis were made with the diameter of 5.5mm-6mm.And then water separation and water stratification were carried out.Stop-and-chop and phacoemulsification were given.The lens cortex was irrigated and absorbed.The anterior chamber was formed with sodium hyaluronate and foldable intraocular lens was implanted into the lens sac.The sodium hyaluronate was irrigated and absorbed and then made the incision watertight.The surgical eye was covered at the end of the surgery.4.Postoperative treatment and follow-upTobramycin dexamethasone eye drops and praventine eye drops were given to reduce inflammation.Complications such like high intraocular pressure,corneal edema were treated in time.Patients were asked for further consultation in our hospital at the time points of 1 week,2 weeks,1 month,3 months for the examination of visual acuity,intraocular pressure,slit lamp microscopy,direct ophthalmoscope and OCT,fundus fluorescein angiography if necessary.5.Research toolsThe Chinese version of Catquest-8SF was developed from the Catquest-9SF using Rasch analysis.The Catquest-9SF was translated into Chinese and re-translated back into English and cultural modificated of the items.The Catquest-8SF consists of 8 items in total;a global daily life difficulty item(item 1),a global vision satisfaction item(item 2)and a group of 6-items referring to difficulties in performing daily activities(item3-8).The daily activity subtable contains 4 visual function items and 2 active items.We also designed the corresponding follow-up questionnaire to record the patients' data such as sex,age,accompanying diseases,education and other basic information and to record subjective symptoms of the eye pain degree in perioperative period.Furthermore,the overall satisfaction and whether it reached the patients'expectations have also been recorded 1 month after the operation.Research results1.The clinical feature in part onePhacoemulsification with posterior chamber SIOL were performed in 840 people with 1,063 eyes in part one who completed at least one month's follw-up.The mean age of the patients was 67.8 years,and 478(56.9%)were women.There were 276(32.9%)patients combined with hypertension,186(22.1%)combined with diabetes and 198(23.6%)combined with cardio-cerebrovascular disease and other systemic diseases.Besides,there were 23.2%operative eye with an ocular comorbidity,14.9%of the operation were complex surgery.2.Postoperative visual acuity recoveryThe PVA improved after surgery in 992 cases(93.3%),was unchanged in 54 cases(5.1%),and became worse in the remaining 17 cases(1.6%).There were 976 cases(91.8%)PVA?0.3 after the surgery.The mean preoperative logMAR visual acuity was 1.12(±0.70),and the mean postoperative logMAR visual acuity was 0.30(±0.35),which was significantly improved after surgery(t= 41.66,P<0.001).PVA>0.3 were observed in 94.0%male patients while in women the number was 90.2%,with statistically significant difference(?2?-5.370,P<0.001).There were 98.5%patients,PVA ?0.3 with no ocular complications,while the number was only 69.2%in patients with ocular complications,the difference was statistically significant(P<0.01).Among the 143 patients aged 80 and above,the postoperative PVA?0.3 in 83.2%patients.3.Surgical complicationsThere were kinds of surgical complications.13 cases(1.22%)of posterior capsular rupture;14 cases(1.32%)of intraoperative floppy-iris syndrome;49 cases(4.61%)of postoperative corneal edema;37 cases(3.48%)of the intraocular pressure higher than 30mmHg on the first day after surgery;7 cases(0.66%)of fibrous exudate in the anterior chamber;5 cases(0.47%)of lenticular cortical residues in the anterior chamber;1 case(0.094%)of acute endophthalmitis after surgery;6 cases(0.56%)of macular edema discovered in the outpatients which has been follow-up visited for 1 month;166 surgical eyes(15.6%)were given Nd:YAG laser treatment because of posterior capsular cataract when follow-up for 36-48 months.4.Low vision after the surgery and the risk factorsThere were 87 cases(8.2%)PVA<0.3 after the surgery,including 84 cases(96.6%)caused by the ocular comorbidity and 3 cases(3.4%)caused by surgical complications.The first three causes of low vision were diabetic retinopathy(DR),age-related macular degeneration(ARMD)and combined with glaucoma,which accounts for 71.2%of the total low vision patients.Other causes included idiopathic macular hole,ischemic optic neuropathy,central retinal artery occlusion and other fundus lesions,amblyopia,high myopia,central corneal spot and other ocular comorbidity.The correlated factors analysis of low vision showed that DR,ARMD,amblyopia,post-vitrectomy,central corneal spot,high myopia and glaucoma weresignificant risk factors for low vision after operation(P<0.05).Age and postoperative corneal edema were also risk factors(P<0.05).Furthermore,gender and posterior capsular rupture were also possible risk factors.5.Analysis of reliability and validity of the Catquest-8SF-CNThe score of every item was positively correlated with the total score(r=0.482?0.733).The Cronbach's a coefficient of the total scale,daily-activity subtable and comprehensive-evaluation subtable were 0.861?0.853 and 0.748 respectively.The Cronbach's a coefficient would decline after deleting any item excluded C8.There was a high level of consistency between the two judges.The total score of the two investigators were highly correlated.The results of SPSS showed that the value of KMO was 0.876 and the value of Bartlett sphericity was 419.95(P<0.001).The cumulative contribution rate was 66.64%calculated by the principal component analysis and the maximum variance orthogonal rotation method.The Catquest-8SF-CN showed high internal consistency reliability,clear factor structure,high variance contribution rate and good structure validity.6.The in:fluence factors of the Catquest-8SF scoreIn the study of part two,120 cataract preoperative patients completed Catquest-8SF questionnaire.The preoperative score of the Catquest-8SF had a significant negative correlation with preoperative binocular weighted logMAR visual acuity(r=-0.452)and age(r=-0.335)(both P<0.05),while a significant positive correlation with education level(F=6.094,P<0.001).The patients without systemic comorbidities got higher score than those who with(P<0.05).There was no statistically significant difference in the score of patients with different gender and whether there was ocular comorbidity(all P>0.05).102 patients completed 3 months follow-up with eye examination and questionnaire filling.Significant improvement of visual acuity was observed in both binocular and monocular surgery groups(t=10.404,P<0.001).There was higher improvement in binocular weighted logMAR visual acuity in binocular surgery group than in monocular surgery group(t=-20.77,P<0.001).The postoperative score was significantly higher in both groups than before(P<0.001).However,there was no significant difference between the two groups in the preoperative score,postoperative score or the improved score(all P>0.05).There was no statistically significant difference between monocular surgery group and binocular surgery group in terms of sex,age,systemic comorbidities,ocular comorbidity or education(all P>0.05).The improved score of the questionnaire was correlated significantly with the improvement of the visual acuity.The improvement of the total score,the score of monocular or binocular surgery group was not obviously influenced by systemic comorbidity,co-existing ocular comorbidity,sex or age.7.The preoperative,intraoperative and postoperative painAll surgeries were completed under facial anesthesia.17 patients(16.7%)had preoperative pain symptom,33 patients(32.4%)had postoperative pain,and 53 patients(16.7%)had intraoperative pain.Among those who had intraoperative pain,51 patients(50%)had mild pain and 2(1.96%)had moderate pain,while no patient with severe pain.8.Overall satisfactionThe overall satisfaction included the patients' satisfaction of preoperative examination and communication,the surgical procedure and the postoperative care and recovery.94 patients(92.2%)were very satisfied or satisfied with the operation.92 patients(90.2%)thought the surgery achieved their expectations.Three months after the operation,different factors such like gender,age,education level,presence of systemic comorbidities or ocular comorbidities,preoperative/postoperative discomfort and pain in surgery had no obvious effect on satisfaction of patients.Correlation analysis showed that the satisfaction was significantly correlated with the improvement of the scale score(P<0.05)and there was no significant correlation between satisfaction and postoperative logMAR visual acuity and improved visual acuity(P>0.05).Conclusion1.The clinical effect of phacoemulsification with posterior chamber SIOL for treating age-related cataract is overall safe and good.The PVA has been improvedgreatly after surgery while the effect was more significantly in men.The risk factors of low vision after surgery included co-existing ocular comorbidity,such as DR,ARMD,glaucoma,the postoperative corneal edema and advanced age,but co-existing ocular comorbidity and advanced age were not contraindications for surgery.It was much more likely to result in low vision for patients with PCR during surgery,so it would be important to treat complications timely and properly.Our Meta-analysis found that phacoemulsification accelerated DR progress and increased the incidence of DME,which may remind us that clinical follow-up should be enhanced and appropriate intervention should be given if necessary.2.The Chinese version of Catquest-8SF questionnaire is suitable for the age-related cataract population in northern China.It is highly responsive to cataract surgery and brief.Because it can evaluate the patient-reported outcome effectively and conveniently,Catquest-8SF-CN has the potential to become part of a routine clinical assessment for cataract surgery in China.There were significantly correlation between the improvement of score and the improvement of visual acuity.Binocular surgery could improve the patients' visual function better,but monocular surgery can achieve the similar improvement of visual functional related quality of life.The influence factors of the questionnaire score also reminded us that we should not only consider the visual function,but also consider the quality of life of the patients in the timing of the surgery,so that to make a more reasonable treatment plan for patients'individual need.3.The patient's overall satisfaction is high,which illustrates that the medical service we provide matches the patient's needs.The degree of satisfaction is significantly correlated with the improvement score of the scale and it's also correlated with their expectation of the surgery.This suggests the most important thing for patients is the improvement of their life quality.It also reminds us that we should attach great importance to the way of preoperative communication with patients,such as using multimedia and communicating with patients according to their individual condition.In this way,patients would have sufficient understanding and appropriate expectations of the surgery,so as to improve their satisfaction. |
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